The following data is part of a premarket notification filed by Magnolia Medical Technologies Inc. with the FDA for Steripath Micro Blood Collection System.
| Device ID | K200661 |
| 510k Number | K200661 |
| Device Name: | Steripath Micro Blood Collection System |
| Classification | Set, Administration, Intravascular |
| Applicant | Magnolia Medical Technologies Inc. 200 West Mercer Street, Suite 500 Seattle, WA 98119 |
| Contact | Gregory J. Bullington |
| Correspondent | Gregory J. Bullington Magnolia Medical Technologies Inc. 200 West Mercer Street, Suite 500 Seattle, WA 98119 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-12 |
| Decision Date | 2020-10-08 |